Blood Treatment Device Priming Devices, Methods, and Systems

ABSTRACT

Simple-to-use systems, methods, and devices for priming replacement blood treatment devices, for swapping the blood treatment devices out, for replacing swapped-out blood treatment devices, and other related operations are described. In embodiments, a blood treatment device can be primed while a therapy is still running. When the replacement blood treatment device is needed, the therapy can be stopped momentarily (less than a minute) for the rapid and safe swap of the blood treatment device. Blood loss can be minimized. The down time from therapy can be minimized.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Divisional of U.S. patent application Ser. No.16/366,714 filed Mar. 27, 2019, which is a Divisional of U.S. patentapplication Ser. No. 15/564,719 filed Oct. 5, 2017, (now U.S. Pat. No.10,279,098), which claims priority under 35 U.S.C. § 371 toInternational Application No. PCT/US2016/026525 filed Apr. 7, 2016,which claims the benefit of U.S. Provisional Application Nos. 62/298,620filed Feb. 23, 2016 and 62/143,880 filed Apr. 7, 2015, all of which arehereby incorporated by reference in their entireties.

REFERENCE TO GOVERNMENT GRANT

This invention was made with Government support under Contract No.HR0011-13-C-0023 awarded by Defense Advanced Research Projects Agency(DARPA). The Government has certain rights in this invention.

FIELD

The present disclosure relates generally to blood treatment devices fora bodily fluid, and, more particularly, to systems, methods, and devicesfor priming of a bodily fluid treatment device, such as a bloodtreatment device.

BACKGROUND

Dialysis and other forms of blood treatment employ blood treatmentdevices that are used to remove water and/or other undesiredconstituents from the blood and restore can also help electrolytes tothe blood of patients. Dialyzers, a type of blood treatment device, forexample, can replace the natural function of the kidney. In dialysisblood is treated outside of the body of the patient by passing itthrough a dialyzer. Hemoperfusion is another type of treatment that usesblood treatment devices. Regardless of the type of treatment, a problemwith using treatment devices such as blood treatment devices anddialyzers is the presence of air or other gas or gasses in the bloodtreatment device prior to connection to a patient. If air or other gasor gasses and/or bubbles are present in the blood treatment device, thepatient may be injured by air or other gas or gasses embolisms or clotembolisms induced by the air or other gas or gasses in the bloodtreatment device and tubing. Priming with fluid such as saline is usedto remove air or other gas or gasses. Priming techniques on dialysisblood lines and blood treatment devices includes pumping the primingfluid through the circuit, hammering, inverting, and shaking the bloodtreatment device while flowing fluid through it in order to remove theair or other gas or gasses and/or bubbles. Automated systems that can beused for priming are also known, but they can inconvenient if it isdesired to prime a blood treatment device to permit it to stand by forreplacement in a system being used for treatment. Also existingautomated systems may tie up the treatment system or be complex.Dialyzers and other blood treatment devices are commonly sold asstandalone products and have labeling that prescribes the amount ofsaline that must be used to prime. The users are obliged to follow theseinstructions, making replacing a blood treatment device during a therapysession very difficult, if not impossible since blood is already in theblood tubing circuit and in the blood treatment device to be replaced.Also, many Continuous Renal Replacement Therapy (CRRT) machines have apreconnected and bonded in place blood treatment device, makingreplacement of the blood treatment device impossible. The CRRTdisposable consists of a blood treatment device, a blood line portionand a therapy fluid portion. During a therapy session, sometimes theblood treatment device becomes exhausted and clogged, but the rest ofthe disposable circuit is still useable. An option is to discard theentire circuit. This takes therapy time away from the patient as thecircuit is swapped, primed, and tested prior to reinitiating thetherapy, and a substantial portion of the disposable cost is thenon-blood treatment device portion.

SUMMARY

Simple-to-use systems, methods, and devices for priming replacementblood treatment devices, for swapping the blood treatment devices out,for replacing swapped-out blood treatment devices, and other relatedoperations are described. In embodiments, a blood treatment device canbe primed while a therapy is still running. When the replacement bloodtreatment device is needed, the therapy can be stopped momentarily (lessthan a minute) for the rapid and safe swap of the blood treatmentdevice. Blood loss can be minimized. The down time from therapy can beminimized.

BRIEF DESCRIPTION OF DRAWINGS

Embodiments will hereinafter be described with reference to theaccompanying drawings, which have not necessarily been drawn to scale.Where applicable, some features may not be illustrated to assist in theillustration and description of underlying features. Throughout thefigures, like reference numerals denote like elements.

FIG. 1 is an image of a drain bag, according to one or more embodimentsof the disclosed subject matter.

FIG. 2 is a drawing of a setup for priming, according to one or moreembodiments of the disclosed subject matter.

FIGS. 3A and 3B show respective drawings of systems that may supportand/or employ the blood treatment device swapping system and method,according to one or more embodiments of the disclosed subject matter.

FIG. 4 is a side view of an interconnector, according to one or moreembodiments of the disclosed subject matter.

FIG. 5 is a longitudinal, cross-sectional view of the interconnector ofFIG. 4, according to one or more embodiments of the disclosed subjectmatter.

FIG. 6 is a drawing of a priming assembly with a pressure monitoring podand three saline spikes, according to one or more embodiments of thedisclosed subject matter.

FIG. 7 is a drawing of a setup for priming using a priming assembly witha pressure monitoring pod similar to that of FIG. 6, except with justtwo saline spikes, according to one or more embodiments of the disclosedsubject matter.

FIG. 8 is a drawing of a priming assembly with vented Hansen caps andthree saline spikes, according to one or more embodiments of thedisclosed subject matter.

FIG. 9 is a drawing of a setup for priming using a priming assembly withvented Hansen caps and three saline spikes similar to that of FIG. 8,according to one or more embodiments of the disclosed subject matter.

FIG. 10 is a drawing of a priming assembly with standard luerconnections and pinch clamps and a single saline spike for use with astandard dialyzer, according to one or more embodiments of the disclosedsubject matter.

FIG. 11 is a drawing of a setup for priming using a priming assemblywith standard luer connections and pinch clamps and a single salinespike similar to that of FIG. 10, according to one or more embodimentsof the disclosed subject matter.

FIGS. 12A and 12B illustrate another method and optionally deviceembodiments for unattended priming of a blood treatment device.

FIGS. 12C and 12D show alignment and positioning mechanisms forarranging a priming set-up that helps to ensure the alignment andpositioning of the various components required according to embodimentsof the disclosed subject matter.

FIG. 12E shows further alignment and positioning mechanisms forarranging a priming set-up that helps to ensure the alignment andpositioning of the various components required according to embodimentsof the disclosed subject matter.

FIG. 12F illustrates a feature for variation of the embodiment of FIG.12E.

FIG. 13 is a method of priming and swapping a blood treatment deviceduring a treatment, according to embodiments of the disclosed subjectmatter.

FIG. 14 is a drawing that represents multiple priming circuitembodiments in which the siphon flow of fluid is starved by preventingflow from the source side of the circuit rather than the filling of adrain container.

FIGS. 15A through 15C are for illustrating a priming method and also toshow a priming fixture configured to implement the method, according toembodiments of the disclosed subject matter.

FIGS. 16A and 16B illustrate various embodiments of a priming circuitand treatment circuit according to embodiments of the disclosed subjectmatter.

DESCRIPTION

Blood treatment devices must be primed with a physiologic fluid likesaline in order to use them in a blood circuit. With some of thedevices, methods, and systems according to the currently disclosedsubject matter, blood treatment devices can be swapped out when thephysician or medical staff determine the useful life has exhausted. Incertain types of treatments, it may be advantageous for blood treatmentdevices to be primed and ready to replace in a blood circuit, forexample, to replace ones currently being used if they become clogged orineffective.

Priming a blood treatment device can be an attention-consuming processbecause it needs to be done in a way that prevents air or other gas orgasses from entering the circuit. Priming replaces air or other gas orgasses in the blood treatment device with physiological fluid, forexample, a blood normal saline solution or a bio-compatible fluid, inpreparation for blood flowing through the blood treatment device. Thisis at least partly due to the fact that air or other gas or gassescontact with blood creates a risk of clotting. Priming also flushes awayimpurities in the blood treatment device. Impurities can exist becauseof residual sterilization chemicals (e.g., ethylene oxide), chemicalsused in manufacturing, or particulates from the manufacture of the bloodtreatment device. Priming can also activate a component of the bloodtreatment device allowing it to perform its specific therapy when incontact with blood. Priming of the blood circuit and blood treatmentdevice is a common practice in dialysis and other blood processingtherapies. After priming, the blood circuit and/or blood treatmentdevice can be subject to flushing, which refers to rinsing additionalfluid through the primed blood treatment device.

There are many different types of blood treatment devices that may beused in blood processing therapies such as perfusion, sepsis therapy,therapeutic plasma exchange, and other similar types of therapy.Different blood treatment devices have some common requirements and somethat differ according to the type or manufacturer. One of thedifferences is whether the priming solution can be given to a patient,or must be flushed from the blood treatment device, prior to use.

In one priming procedure, a bag of fluid is spiked to allow gravity flowinto a blood treatment device to be primed. Fluid exiting the bloodtreatment device was sometimes captured in a drain bag. The priming ofblood treatment devices may require the user to watch the process inorder to stop the saline flow before the saline bag empties, lest air orother gas or gasses enter the blood treatment device. If the user getsdistracted, the saline bag could empty, pulling air or other gas orgasses into the just-primed blood treatment device. This requires, at aminimum, that the priming process be redone in order to remove thisnewly introduced air or other gas or gasses prior to connection of theblood treatment device to the patient. With many blood treatment devicesre-priming is not possible, because once the internal material is wettedand then air or other gas or gasses is introduced, the air or other gasor gasses attaches to the material due to surface tension which reducesthe effective surface area of the blood treatment device and results inperiodic venting of air or other gas or gasses into the blood line.

According to one or more embodiments of the disclosed subject matter, abetter priming procedure and apparatus can provide for flushing theblood treatment device separately from the blood processing machineusing, for example, an ancillary disposable blood treatment devicepriming set. In an embodiment of a blood treatment device priming set,an assembly includes tubing with a bag spike and a drain bag of apredefined configuration. The described blood treatment device primingset and method of use allow for error proof priming by stopping thesaline automatically prior to the emptying of the saline bag byemploying a drain bag whose volume is selected to keep air or other gasor gasses from entering the blood treatment device. In embodiments, thisdrain bag maximum volume is less than a total volume of the primingfluid. In further embodiments, this drain bag maximum volume is lessthan a total volume of the priming fluid plus the volume of the bloodtreatment device plus the volume of the priming circuit downstream ofthe blood treatment device. The purpose of the drain bag is to capturethe saline that is gravity fed through the blood treatment device and tostop the flow once the bag has reached its fill capacity. This alsocaptures the used saline, which is now considered waste, for easy andconvenient disposal. In embodiments, the condition can be ensured byensuring that a source container, such as a bag, cannot drain fully,maintaining a fluid “head” above the level of the blood treatment devicebeing primed by gravity flow. In further embodiments, the volume may beless, but at least the possibility that the fluid flow through the bloodtreatment device may draw air or other gas or gasses into the bloodtreatment device is eliminated. Note that in alternative embodiments, ifa sealed priming circuit can be assured, the drain container can have alarger volume than the embodiments described above if the flow of fluidcan be halted by a vacuum on the supply side of the priming circuit. Forexample, if air or other gas or gasses is eliminated from a container ofpriming fluid and the priming circuit, the fluid can drain from it untila negative pressure develops in the priming fluid container. Thenegative pressure may be generated by the collapse of the priming fluidcontainer and/or simply result from the draw-down of fluid in the casewhere the priming fluid container is a rigid container that. Both mayhave the effect of shutting down the siphon head of the priming circuit.Any of the features of the device, system, and method embodimentdisclosed herein may be employed in such an embodiment. Effectively, theflow of the priming circuit here is halted by a negative pressuregenerated upstream rather than a positive pressure downstream.

The bag spike allows for the connection of the priming set tocommonly-used priming solution bags. In general, normal saline is thepriming solution of choice and these bags are typically 1 liter involume. In an example, the blood treatment device priming set will have2 bag spikes for 2 bags of saline for a 2 liter prime and flush.Alternatively, the blood treatment device priming set can have one spikefor a 1 liter prime and flush. In yet another alternative, the bloodtreatment device priming set can have 3 spikes for a 3 liter prime andflush, in order to allow for greater priming volumes. Other numbers ofspikes and volumes for priming and flushing are also possible accordingto one or more contemplated embodiments.

The drain bag of the priming set can be of a material selected to ensurethat any stretching that may occur at predefined temperatures isinsufficient to prevent the arrest of the flow that ensures that air orother gas or gasses cannot enter the blood treatment device. Forexample, it is known that flexible PVC bags can stretch to large sizeswith very little pressure due to the large surface area of the bag. Animage of an exemplary drain bag 100 is shown in FIG. 1. Common PVC drainbags may stretch and not perform as intended. In contrast, the drain bagaccording to one or more embodiments of the disclosed subject matter isless elastic than PVC. In further embodiments, the drain bag can beinelastic. For example, the drain bag is of a multilayer film with hightensile rigidity layer or layers. In still further embodiments, aheat-welded bag made of a nylon outer layer and a polyethylene innerlayer may be employed. The thickness is generally between 1 and 6 mil,but generally 3 to 4 mil. Alternatively, or additionally, the drain bagcan be placed in a rigid support, such as a tank or a non-expandablepouch that prevents a drain bag of elastic material from expanding. Thelatter can be a reusable component attached to a blood treatmentmachine.

In another example of a blood treatment device priming set 201 of apriming setup 200, as shown in FIG. 2, with the blood treatment devicepriming set 201 includes 2 bag spikes 203 and a drain bag 230 has acapacity of 1.5 liters, which is more than the priming volume of a bloodtreatment device 220, the priming volume of the blood treatment devicepriming set 201. In the priming fluid circuit 200, multiple saline bags210 are hung a height above a blood treatment device 220, which in turnis mounted above a drain bag 230. The vertical elevation differencebetween the saline bags 210 and the drain bag 230 can generate a siphoneffect that draws fluid through the blood treatment device 220. Theelevation difference may be used to select the speed at which the bloodtreatment device 220 is primed. Also the tubing diameters can be used toselect speed of priming. Note that as used here, priming may alsoinclude flushing in that more than a quantity merely sufficient forfilling the fluid may flow through the priming circuit 200 in order topurge air or other gas or gasses and undesirable materials such asmanufacturing residuals from the blood treatment device 220. Thevertical elevations can be optimized for the variety of blood treatmentdevices anticipated to be used and to allow for a prime of each type ofblood treatment device within a predefined period of time.

In the illustration of the two bag spike example in FIG. 2, the two bagsof saline 210 are hung, for example, on an IV pole or equivalentsupport, and spiked so that the saline flows into tubing 202 a-202 cthat connected to output ends of the bag spikes 203. The tube lengths202 a join at a Y-junction 205. Flow from the bags of saline 210 flowsto an arterial blood circuit connector of the blood treatment device 208(the nomenclature arterial blood circuit applies to dialysis andhemofiltration blood treatment devices but other types of bloodtreatment devices may be primed using the devices and method described),fills the blood treatment device 220, exits the blood treatment devicethrough a venous connector 209, then flows through a drain line 202 d,202 e to a drain container (bag) 230. The dialyzer may be held in aholder that orients it such that the saline flows from bottom to top.This flow direction helps to eliminate air or other gas or gasses byexploiting buoyancy. The drain bag may be hung at a location below thatof the saline bags. The saline flows through the blood treatment device220 and into the drain bag 230 until the drain bag 230 has reached itscapacity, whereupon the flow stops automatically due to the stiffness ofthe drain bag 230 and the predefined volume thereof. Once the bloodtreatment device 220 is primed (flushed as well), the blood treatmentdevice and the tube lengths 202 c and 202 d as well as male 206 a andfemale self-sealing 207 connectors can be disconnected, therebyself-sealing, and reconnected in a treatment circuit to replace a bloodtreatment device currently in use as illustrated in FIGS. 3A and 3B.

By halting the flow of priming fluid in the manner described, a bloodtreatment device 220 is primed in an unattended fashion. That is, theuser performing the priming does not have to observe, and timely halt,the priming process in order to ensure that no air or other gas orgasses enters the blood treatment device 220. Ordinarily, the flow wouldbe stopped by engaging a pair of pinch clamps 204 (or elsewhere to thesame effect).

In embodiments, in addition to the gravity priming and automaticstopping of the priming process, a tubing set for priming bloodtreatment devices can include self-sealing connectors 211 that eliminatethe need for pinch clamps by opening the fluid path upon connection andsealing fluid prior to connection or after disconnection. Such valvesare available off the shelf, for example, but not limited to,Halkey-Roberts connectors 211, 212 which have a male connector half 206,206 a and a female connector half 207, 207 a. Halkey Robertsself-sealing connectors are readily available on the market. Howeverother self-sealing connectors could be employed or non-self-sealingconnectors with manual tube clamps could be employed. As well, the useof self-sealing connectors is not required to take advantage of the easypriming technique. For example, but not limited to, standard male andfemale luer connections can be used, as well as any number of fluidconnections available, such as DIN Connectors. Self-sealing connectorsare particularly advantageous in hemoperfusion therapies with highlycontagious diseases such as ebola or HIV. By making the sealing andclosing off of the circuit automatic, there is less likelihood ofcontamination of the treatment environment and/or the medical staff

In general, standard dialyzers and blood treatment devices employdialyzer connectors that are the same at both ends of the dialyzer. Thismakes it possible to connect the dialyzer incorrectly. For a dialyzer toperform most efficiently there must be counter current flow of the bloodrelative to the dialysate flow. If the flows are parallel, then there isa loss in clearance of toxins through the membrane due to a reducedosmotic gradient. In a method according to one or more embodiments ofthe disclosed subject matter, immediately after an extracorporeal bloodtubing set is primed, which can include after the patient has beenconnected, primed blood treatment devices that have been primed by thedevices and methods disclosed, can be connected into a blood circuit 300in a safe manner without blood loss, as illustrated by FIGS. 3A and 3B.

FIG. 3A shows a system 380 that employs and supports swapping of bloodtreatment devices. The system 380 includes one or more blood treatmentdevice priming sets 395, each of which includes a fluid circuit 392 thatinterconnects a source container 389 with priming fluid, a bloodtreatment device 388, and a drain container 390. Each of the bloodtreatment devices 388 i through 388 k may be any type of treatmentdevice and the one or more multiple blood treatment devices 388 ithrough 388 k may be of any of the types listed above. The fluidcircuits 392 may be of any of the types described herein, preferablythose embodiments that are effective for permitting unattended primingof a respective blood treatment device 388 i through 388 k.

FIG. 3B shows a treatment fluid circuit that includes blood treatmentdevices 320 and 321 as well as a dialyzer 350. The 320 and 321 as wellas a dialyzer 350 may be any type of treatment device and may be anynumber. In an embodiment, there are multiple types, such as illustrated,where a patient may be treated for multiple conditions including renalfailure, sepsis (removal of bacterial particles), or other conditions.The different types of treatment devices (illustrated by way of exampleby 320 and 321 as well as a dialyzer 350) may include hemofilter,dialyzers, apheresis blood treatment devices, adsorbent blood treatmentdevices, sepsis filter, and other types of treatment devices. Thisdisclosed subject matter is applicable for the priming and use of newand yet to be developed blood treatment device technologies. By allowingthe blood treatment device to be primed separately from the therapymachine and blood/therapy fluid disposable, the flexibility available tothe physician increases. A review of priming requirements of variouscurrently marketed blood treatment devices makes incorporating anautomated priming sequence into a therapy machine difficult withoutconstant software updates for each new blood treatment device type.Blood treatment devices 382 which may be of any type, including a mix oftypes, may be replaced by blood treatment devices 388 i through 388 k.Again, all the blood treatment devices illustrated in FIG. 3A andelsewhere are understood to be any type of treatment device asidentified anywhere herein. The only limitation in terms of theunattended priming feature of the disclosed subject matter is that suchtreatment devices may benefit from, or require, priming and mostpreferably benefit from advance priming prior to installation on a fluidcircuit.

FIG. 3B also shows further parts of the system 380 including a treatmentsystem 387 that includes a treatment machine 381 that has pumps 384 andother elements that engage a fluid circuit 383. The fluid circuit 383,which may be disposable, interconnects one or more of the bloodtreatment devices 382, which again may be of different types from eachother according to one or more treatments being provided. One or more ofthe blood treatment devices are replaceable with one or more of theblood treatment devices 388 i through 388 k. The fluid circuit 383 mayinterconnect the blood treatment devices 382 in any manner according toa type of treatment. Not shown, but possibly being present, is a patientwho may be connected by the fluid circuit 383. The pumps 384 may beperistaltic pumps or any other type of pump. The fluid circuit 383 mayinclude blood handling elements such as one or more of tubes, pressurepods, drip chambers, junctions, temperature sensors, pumping tubesegments, and other elements of a blood handling fluid circuit. Thetreatment machine 381 may include temperature and pressure transducers,pump actuators, valve clamps, and other elements that may be employed incurrent or future types of treatment machines.

In an example system 300, illustrated in FIG. 3B, the blood treatmentdevices 320 and 321 may be sepsis filters. A treatment machine 370 has adisplay/control panel 360, a dialytic blood treatment device 350, sepsisfilters 320 and 321 which are connected using self-sealing connectors311, 321, 331 that convey blood being treated through the sepsis filters320 and 321. A replacement fluid 340 may be provided through a line 341and waste fluid drained through a line 371. Blood lines 372 may transferblood to and from a patient.

In embodiments, it may be desirable to prime portions of a blood circuitseparately from other parts. For example, sepsis filters may containmaterials for storage and preservation or manufacturing products thatmust be cleansed from them prior to use. It may also be the case that itis undesirable for a priming fluid that is used to cleanse one sepsisfilter to flow into another sepsis filter or other device. For example,that would be the case if the system of FIG. 3B were primed in thecommon manner of flowing priming fluid through the entire treatmentcircuit prior to performing the treatment. This may result in primingfluid causing cross-contamination, in effect, or increasing the volumeof fluid required to fully remove the materials to be washed out. Alsosome blood treatment devices may not be compatible with the materialsbeing purged from other blood treatment devices. In such cases, some orall the blood treatment devices in a single circuit may be primedindividually according to the disclosed methods above and below andusing the devices described. So this is an additional function providedby the disclosed priming devices, methods and systems.

During a treatment procedure, the treatment system 387 may be observedby an operator who may identify a need for the change of any of the oneor more blood treatment devices 382. Upon an identification of a need tochange the any of the one or more blood treatment devices 382, the usermay set up any one or more of the one or more fluid circuits 392 forunattended priming of one or more corresponding blood treatment devices388 i through 388 k and then prime it/them.

In a method embodiment, blood treatment device 320 is replaced byanother, such as blood treatment device 220 of FIG. 2, which haspreviously been primed as discussed with reference to FIG. 2. To dothis, self-sealing connectors 211 and 212 of FIG. 2 are separatedisolating a priming fluid volume in the blood treatment device 220 andthe lines 202 c and 202 d and making accessible the female connector 207and male connector 206 a of the self-sealing connectors 211 and 212.Corresponding self-sealing connectors 321 and 331 (FIG. 3B) may then beseparated and the self-sealing connectors 211 and 212 mated to thecorresponding male and female connectors mated to replace bloodtreatment device 320.

Embodiments may employ self-sealing connectors or regular connectorswith clamps. With self-sealing connectors 311, 321, 331, there is areduced risk of loss of fluid from the primed blood treatment device orloss of blood from the receiving fluid circuit when the disconnection ismade. Then when lines are connected (by making the self-sealingconnector connections), the connections open up allowing flow of thefluid or blood.

It is noted that the type of blood treatment device or other deviceprimed using the devices and methods above may be varied. In addition tothe above-described sepsis filters, embodiments of the disclosedtechnique are applicable to dialyzers, hemofilters, perfusion bloodtreatment devices, therapeutic plasma exchange blood treatment devicesand other devices that need to be primed prior to being connected to anextracorporeal blood tubing set for blood delivery to a blood treatmentdevice and return to a patient.

In order to facilitate interchangeability of various types of bloodtreatment devices using the described methods and devices, it may beimportant to have consistent connection types within a given productline, which, for example in this case, the male connector will alwayspoint in the direction of the intended fluid flow. This will ensure thatthe resulting primed blood treatment device or blood treatment deviceswill be connected properly. It also allows for multiple blood treatmentdevices to be connected in series, if desired.

The above-described embodiments use the Halkey Roberts valve 211 withmale and female connectors 206, 207. Other types of self-sealingconnectors are known and may be used as well. These make connectionconvenient because the connections are self valving and no pinch clampsare required. However, these connectors cannot be packaged and stored inthe open position as the elastomer (typically silicone) valve parts canbe permanently affected due to material creep. To facilitate the use aswell as packaging and storage of the priming set, an interconnector 400as seen in FIG. 4 and FIG. 5 may be employed. This interconnector 400may be brightly colored, or otherwise configured to make conspicuous tothe user the fact that it is removable. The interconnector 400 may beshaped to hold the male and female self-sealing connections togetherwithout activating or opening the valves. The interconnection may holdthe self-sealing connectors in an inline arrangement such that theiraxes are collinear just as when they are connected, except that they arefurther apart. This interconnection arrangement is used during storageand shipping and mimics the interconnections that are made during use ofthe fluid circuit but without activating the automatic valves whichwould cause the elastomer that causes automatic closure to creep duringstorage. The distinguishing features such as colors and the tab 410 helpthe user to notice and remember to remove the interconnector prior touse. By packaging the components held together by the interconnector400, it makes it easier for the user to recognize and establish thecorrect interconnections as well as prevent entanglement of tubing thatcould make interconnection more difficult. In addition, the therapymachine may display an appropriate software instruct the user how to usethe priming set up, how to remove the inter connector, how to reconnect,perform the prime, and how to insert in the newly primed blood treatmentdevice in series or replace and existing blood treatment device.

FIG. 5 illustrates a cross section of the interconnector in FIG. 4. Thesection is taken through the plane indicated at A-A in FIG. 4. In thisembodiment of the disclosed subject matter, the interconnector 400 isdesigned to not seal with standard luer connectors, but instead to actas a sterile barrier cap as well as holding the assembly together so theuser knows how the assembly is to be configured for use. Theinterconnector is also configured to provide an interference fit withthe mating connectors to help ensure they do not inadvertently fall offin shipping and storage. Specifically, the interconnector 400 includes amale connection end 510 that is configured to connect to the maleconnector half 206 of the self-sealing connector 211 and a femaleconnection end 520 that is configured to connect to the female connectorhalf 207 of a self-sealing connector 211, for example, a Halkey-Robertsvalve 211. As seen in FIG. 5, an interior wall 530 extends across thediameter of the connector 400 and between the male connection end 510the female connection end 520 and prevents any fluid communicationbetween the male connector half 206 of the self-sealing connector 211and the female connection end 520. In the embodiment of FIG. 6, forexample, the interconnector ties the self-sealing connectors 611 and611′ together without permitting flow between them and withoutactivating and distorting the elastomeric material used by theself-sealing connectors 611 and 611′ (e.g., Halkey Roberts-typeconnectors) during storage of a fluid circuit. Such activation opens aself-sealing elastomeric seal by distorting it, which if maintained fora long time as in storage, would cause creep and could prevent it fromre-sealing.

FIG. 6 is a drawing of a fluid circuit set that according to the methodand devices described above. A packaged fluid circuit 601 may beprovided in a sterile bag 650. The fluid circuit may contain componentsfor use with the blood circuit for example, it may optionally include apressure monitoring pod 640. A plurality of bag spikes 603 may beprovided for accessing a source (e.g. bag) of saline. Self-sealingconnector set 611 and 611′ in the priming assembly 601 for perfusionblood treatment devices or sepsis filters (for example, for a 3 Spikeversion) as it would come out of the packaging separated by theinterconnector 400, including the pressure monitor pod 640. Such bloodtreatment devices as illustrated in FIG. 6 may lack filtrate ports. Forexample, a sepsis filter may have microtubular fibers that are coatedwith binding agent and may be arranged such that no flow through thewalls of the fibers occurs. In this embodiment of the blood treatmentdevice priming set 601, there are multiple bag spikes 603, for example3, each with a tube 602 a with one each connected to an outlet end ofone of the 3 bag spikes 603, and closeable by a respective pinch clamp604. A diverging connector 605 with the 3 input ends connected to the 3tubes 602 a and the 1 output connected to an input end of a secondlength of tubing 602 b that is in turn connected at an output end to amale part 606 of the self-sealing connector set 611. An opposite end ofthe male half 606 is connected to the male connection end 510 of theinterconnector 400 and the female connection end 520 of theinterconnector 400 is connected to the female half 607 of theself-sealing connector set 611. An output end of the female half 607 maybe connected to an input end of a third length of tubing 602 c and anoutput end of the third length of tubing 602 c is connected to a DINconnector 608 (see ANSI/AAMI/ISO 8637-2010), which in this embodiment iscolor coded red to aid in the correct connection with the bloodtreatment device.

A second DIN connector 609 may be connected to an input end of thepressure measurement pod 640 and an output end of the pressuremeasurement pod 640 (which may be generally configured as described inUS patent publication 20070179422 to Schnell or alternatives are similardevices such as inline pressure transducers) may be connected to aninput end of a fourth length of tubing 602 d. In this embodiment, thesecond DIN connector 609 may be color coded, for example the color blue,to aid in the correct connection with the blood treatment device whichmay be correspondingly color coded. An output end of the fourth lengthof tubing 602 d is connected at an output end to a male half 606′ of asecond self-sealing connector set 611′. An opposite end of the male half606′ may be connected to the male connection end 510′ of a secondinterconnector 400′ and the female connection end 520′ of the secondinterconnector 400′ may be connected to the female half 607′ of theself-sealing connector set 611′. An output end of the female half 607′may be connected to an input end of a fifth length of tubing 602 e andan output end of the fifth length of tubing 602 e may be connected to adrain bag 630 with a capacity of 2.5 liters, which is the priming volumeof a blood treatment device (not shown), the priming volume of the bloodtreatment device priming set 601 and an amount to take into accountvariation in amount of saline and priming volumes. A fourth pinch clamp604′ may be attached around and configured to close the fifth length oftubing 602 e just before the drain bag 630.

In a method according to one or more embodiments of the disclosedsubject matter, saline bags (not shown in FIG. 6 but as illustratedelsewhere, for example at 710 or 210 in FIG. 2) that are connected tothe saline spikes 603 are hung at a height above the blood treatmentdevice (also not shown, but see 220 from FIG. 2), which in turn ismounted above the location of the drain bag 630, as illustratedschematically in FIG. 6. The vertical distance between the saline bags,the blood treatment device and the drain bag 630 can determine the speedat which the blood treatment device may be primed and flushed. Bypositioning the saline bags (not shown in FIG. 6 but as illustratedelsewhere, for example at 710) above the blood treatment device and thedrain bag 630 below the saline bag or bags sufficient to produce asiphon effect, the blood treatment device is primed. The verticaldistances can be optimized for the variety of blood treatment devicesanticipated and allow for a prime within a predefined period of time.For example, the net fluid column can be adjusted to produce a desiredpressure differential and concomitant flow rate by adjusting therelative elevations of saline bags and drain bag 630.

In the illustration of the multi spike example in FIG. 6, although notexplicitly shown, the bag or bags of saline are hung and spiked so thatthe saline fills the tubing 602 a-c up to the connection of the bloodtreatment device, fills the blood treatment device, then fills the drainline 602 d-e after the blood treatment device. The saline flows viagravity through the blood treatment device and into the drain bag 630.The flow continues until the drain bag 630 has reached its capacity,then the flow stops automatically. A benefit of this technique is thatthe user performing the priming does not have to observe and halt thepriming process in order to prevent air or other gas or gasses enteringthe blood treatment device. A further benefit is that the bloodtreatment device may be primed consistently by different workers using apredefined volume of saline. Note that other types of priming fluid maybe used.

In embodiments, a tubing set for priming blood treatment devices mayinclude self-sealing connectors that eliminate the need for pinch clampsby opening the fluid path upon connection and sealing fluid whendisconnected either prior to or after priming. Such valves are availableoff the shelf, for example, but not limited to, Halkey-Robertsconnectors 211, which have a male connector half 206 and a femaleconnector half 207. As mentioned elsewhere, these self-sealing valvesmay employ an elastomer that is subject to creep which can underminetheir ability to seal.

FIG. 7 is a drawing of a setup for priming 700 using a priming assembly701 with a valve 711, a pressure measuring/monitoring pod 740 and adrain bag 730 similar to that of FIG. 6, having 2 saline spikes 703,according to one or more embodiments of the disclosed subject matter.FIG. 7 shows the priming assembly 701 (2 Spike version) with a pressuremeasuring/monitoring pod 740 after it is connected to a Sepsis filter720 for the priming step.

In FIG. 7 a blood treatment device priming set 701, similar to bloodtreatment device priming set 600, has 2 bag spikes 703 that carrypriming fluid through 2 tubes 702 a with join at a Y-branch 705. Pinchclamps 704 may be attached at any point along the fluid circuit to haltflow and prevent leaking of fluid. Priming fluid flows through tubes 702a a length of tubing 702 b that is in turn connected at the self-sealingconnector 711. The self-sealing connector 711 includes mating male 706and female 707 parts. The female part 707 is connected to a third lengthof tubing 702 c which leads to a DIN connector 708, which may be colorcoded to aid in the correct connection with the blood treatment device720. A second DIN connector 709 is connected to a pressure measurementpod 740 and in turn connected to a fourth length of tubing 702 d. Thesecond DIN connector 709 may also be color coded to aid in the correctconnection with the blood treatment device 720. The fourth length oftubing 702 d leads to a male part 706′ of a second self-sealingconnector 711′. A female part 707′ of the self-sealing connector 711′ isconnected through line 702 e to a drain bag 730. In embodiments, thedrain bag 730 has a capacity of 1.5 liters, which is a selected primingand flushing volume of a blood treatment device (not shown), which maytake into account the volume of the blood treatment device priming set701 and a volume determined to desirable for flushing the bloodtreatment device of air or other gas or gasses and other materials, forexample manufacturing residual materials.

In a method according to one or more embodiments of the disclosedsubject matter, but with specific reference to the embodiment of FIG. 7,in the priming setup 700 multiple saline bags 710 are hung a heightabove the blood treatment device 720, which in turn is mounted above thedrain bag 730, as illustrated schematically in FIG. 7. The verticaldistance between the saline bags 710, the blood treatment device 720 andthe drain bag 730 can determine the speed at which the blood treatmentdevice is primed and flushed. As long as the saline bags 710 are abovethe blood treatment device 720 and the drain bag 730 is below the salinebag, the blood treatment device 720 will prime. The vertical distancescan be optimized for the variety of blood treatment devices anticipatedto be used and to allow for a prime of each type of blood treatmentdevice within a predefined period of time.

In the illustration of the two bag spike example in FIG. 7, the two bagsof saline 710 are hung and spiked so that the saline fills tubing 702a-702 c that is connected to output ends of the bag spikes 703 up to aconnection of the blood treatment device 708, fills the blood treatmentdevice 720, fills the pressure measurement pod 740, then fills a drainline 702 d, 702 e after the pressure measurement pod 740. The salineflows via gravity through the drain lines 702 d, 702 e, the second valve711′ and into the drain bag 730. The flow continues until the drain bag730 has reached its capacity, then the flow stops automatically due tothe volume limitation of the drain bag 730. As above, the benefit ofthis technique is that the user performing the priming does not have toobserve and halt the priming process in order to ensure that no air orother gas or gasses enters the blood treatment device 720. The flow canbe stopped by engaging a pair of pinch clamps 704 that are connectedaround the tubing sections 702 a connected to the bag spikes 703.

In embodiments, in addition to the gravity priming and automatic haltingof the priming process, a tubing set for priming blood treatment devicescan include self-sealing connectors 711, 711′ that eliminate the needfor pinch clamps by opening the fluid path upon connection and sealingfluid prior to connection or after disconnection. Such valves areavailable off the shelf, for example, but not limited to, Halkey-Robertsconnectors 711, which have a male connector half 706, 706′ and a femaleconnector half 707, 707′.

FIG. 8 shows a priming assembly 801 in a sealed package 850 with ventedHansen caps 840. The Hansen caps may be of any type that can vent air orother gas or gasses from the non-blood side of a blood treatment device,preferably without loss of priming fluid. A description of the use ofvented caps in priming as well as other details that may be employed inconnection with the currently-disclosed subject matter is described inUS Patent Publication 20150367062 to Brugger. The recommendations inthis publication, such how to orient the blood treatment device, theflow direction during priming, etc. are applicable here as well. In FIG.8, the circuit is generally the same as the embodiment of FIG. 6 exceptthat it has no pressure pod 640 and does include the venting Hansen caps840. Note that venting caps could also be included in the embodiment ofFIG. 6 as well. The venting caps 840 allow for the priming of thedialysate portion of a dialyzer by venting air or other gas or gassesthrough the Hansen caps which are basically vented caps that block theflow of water, for example using a gas permeable hydrophobic membrane.

In the embodiment of the blood treatment device priming set 801 shown inFIG. 8, there are 3 bag spikes 803, 3 tubes 802 a with one eachconnected to an outlet end of one of the 3 bag spikes 803, 3 pinchclamps 804 attached around each tube 802 a are positioned to close the 3tubes 802 a, a 3 input and 1 output connector 805 with the 3 input endconnected to distal ends of the 3 tubes 802 a and the 1 output connectedto an input end of a second length of tubing 802 b that is in turnconnected at an output end to a male half 806 of the self-sealingconnector 811. An opposite end of the male half 806 is connected to themale connection end 510 of the interconnector 400 and the femaleconnection end 520 of the interconnector 400 is connected to the femalehalf 807 of the self-sealing connector 811. An output end of the femalehalf 807 is connected to an input end of a third length of tubing 802 cand an output end of the third length of tubing 802 c is connected to aDIN connector 808, which in this embodiment is color coded red to aid inthe correct connection with the blood treatment device.

A second DIN connector 809 is connected to an input end of a fourthlength of tubing 802 d, in this embodiment the second DIN connector 809is color coded blue to aid in the correct connection with the bloodtreatment device. An output end of the fourth length of tubing 802 d isconnected at an output end to a male half 806′ of a second self-sealingconnector 811′. An opposite end of the male half 806′ is connected tothe male connection end 510′ of a second interconnector 400′ and thefemale connection end 520′ of the second interconnector 400′ isconnected to the female half 807′ of the self-sealing connector 811′. Anoutput end of the female half 807′ is connected to an input end of afifth length of tubing 802 e and an output end of the fifth length oftubing 802 e is connected to a drain bag 830 with a capacity of 2.5liters, which is the priming volume of a blood treatment device (notshown), the priming volume of the blood treatment device priming set 801and an amount to take into account variation in amount of saline andpriming volumes. A fourth pinch clamp 804′ is attached around andconfigured to close the fifth length of tubing 802 e just before thedrain bag 830. The kit shown in FIG. 8 may be provided in a sealed bag850 as a product of manufacture for priming predefined blood treatmentdevices to permit them to be swapped out during a treatment such asdialysis. The priming solution may be provided in the kit as well. Thecontents of the sealed bag 850 may be sterilized, for example bysterilizing the bag 850 and contents after sealing.

FIG. 9 is a drawing of a fluid circuit for priming 900 using a primingassembly 901 with vented Hansen caps 840, but only 2 saline spikes 903similar to that of FIG. 8, according to one or more embodiments of thedisclosed subject matter. FIG. 9 shows the priming assembly 901 (2 Spikeversion, similar to FIGS. 1 and 7) after it is connected to a dialyzerblood treatment device for the priming step, but with vented Hansen Caps840 being added.

As used throughout the specification, the term Hansen cap and Hansenconnector can be replaced with any type of cap and connector suitablefor the function discussed. Hansen connectors are commonly used in fluidconveyance devices and are common on microtubular blood treatmentdevices, but other types can also be used and the disclosed subjectmatter is not limited to the use of these examples of particular typesof connectors, ports, or the caps therefore.

In the embodiment shown in FIG. 9 of the blood treatment device primingset 901, there are the 2 bag spikes 903, 2 tubes 902 a with one eachconnected to an outlet end of one of the 2 bag spikes 903, 2 pinchclamps 904 attached one each around and configured to close the 2 tubes902 a, a 2 input and 1 output “Y” connector 905 with the 2 input endconnected to distal ends of the 2 tubes 902 a and the 1 output connectedto an input end of a second length of tubing 902 b that is in turnconnected at an output end to the valve 911. The valve 911 includes amale half 906 and a female half 907. An output end of the female half907 is connected to an input end of a third length of tubing 902 c andan output end of the third length of tubing 902 c is connected to a DINconnector 908, which in this embodiment is color coded red to aid in thecorrect connection with the blood treatment device 920. A second DINconnector 909 is connected to an input end of a fourth length of tubing902 d, in this embodiment the second DIN connector 909 is color codedblue to aid in the correct connection with the blood treatment device920. An output end of the fourth length of tubing 902 d is connected atan output end to a male half 906′ of a second valve 911′. An oppositeend of the male half 906′ is connected to a female half 907′ of thevalve 911′. An output end of the female half 907′ is connected to aninput end of a fifth length of tubing 902 e and an output end of thefifth length of tubing 902 e is connected to a drain bag 930 with acapacity of 1.5 liters, which is the priming volume of a blood treatmentdevice (not shown), the priming volume of the blood treatment devicepriming set 901 and an amount to take into account variation in amountof saline and priming volumes. A fourth pinch clamp 904′ is attachedaround and configured to close the fifth length of tubing 902 e justbefore the drain bag 930.

In a method according to one or more embodiments of the disclosedsubject matter, but with specific reference to the embodiment of FIG. 9,in the priming setup 900 multiple saline bags 910 are hung a heightabove the blood treatment device 920, which in turn is mounted above thedrain bag 930, as illustrated schematically in FIG. 9. The verticaldistance between the saline bags 910, the blood treatment device 920 andthe drain bag 930 can determine the speed at which the blood treatmentdevice is primed and flushed. The saline bags 910 may be elevated abovethe blood treatment device 920 and the drain bag 930 below the salinebag, the blood treatment device 920 will prime. The vertical distancescan be optimized for the variety of blood treatment devices anticipatedto be used and to allow for a prime of each type of blood treatmentdevice within a predefined period of time.

In the illustration of the two bag spike example in FIG. 9, the two bagsof saline 910 are hung and spiked so that the saline fills tubing 902a-902 c that is connected to output ends of the bag spikes 903 up to aconnection of the blood treatment device 908, fills the blood treatmentdevice 920, then fills a drain line 902 d, 902 e. The saline flows viagravity through the drain lines 902 d, 902 e, the second valve 911′ andinto the drain bag 930. The flow continues until the drain bag 930 hasreached its capacity, then the flow stops automatically. Air or othergas or gasses flows from the dialyzer ports through the Hansen caps 940as the blood treatment device 920 is flushed and primed but fluid doesnot leave the fluid compartment because of the hydrophobic membrane. Inthis way, air or other gas or gasses is completely purged. Because thisis done in an unattended manner, the length of time for priming is lessurgent (the attending user does not need to stand by while the primingproceeds). The flow can be halted by engaging a pair of pinch clamps 904that are connected around the tubing sections 902 a connected to the bagspikes 903.

In embodiments, in addition to the gravity priming and automaticstopping of the priming process, a tubing set for priming bloodtreatment devices can include the first and second valves 911, 911′ thateliminate the need for pinch clamps by opening the fluid path uponconnection and sealing fluid prior to connection or after disconnection.Such valves are available off the shelf, for example, but not limitedto, Halkey-Roberts connectors 911, which have a male connector half 906,906′ and a female connector half 907, 907′.

FIG. 10 is a drawing of a priming assembly 1001 with standard luerconnections 1040, 1041 and pinch clamps 1004 and a single saline spike1003 for use with a standard dialyzer/blood treatment device 1020,according to one or more embodiments of the disclosed subject matter. InFIG. 10, a dialyzer configuration with the priming assembly 1001 as itwould come out of the sterile packaging pre-attached to the bloodtreatment device 1020. Standard DIN Connectors 1008, 1009 and LuerConnectors 1040, 1042 are used, but in this configuration the Maleconnections point in the direction of fluid flow. Specifically, primingof the blood treatment device 1020 occurs through a first length oftubing 1002 a that is connected to the saline spike 1003, through thefemale DIN connector 1008 and into the bottom of the blood treatmentdevice 1020 and up to the top and out through the male DIN connector1009 and into a second length of tubing 1002 b and into a drain bag1030. A female Luer 1040 is used at the dialysate entry and a male Luer1042 is used at the dialysate exit, however, unlike with the priming,the flow of dialysate occurs through the top and then down through thebody and the out the bottom of the blood treatment device 1020. In orderto eliminate the possibility of incorrect connections, a female DINconnector 1009 is located at the entry for the blood path and a male DINconnector 1008 is located at the exit of the blood path. There is ageneral color coding that is used, Red for arterial (blood in), Blue forvenous (blood out), Green for dialysate in, and Yellow for dialysateout. The vents 1041, 1043, in this case Transducer Protectors with microporous membranes 1041, 1043, are used to allow the air or other gas orgasses out of the dialysate compartment, but keep the saline in. Thisallows the dialysate compartment to be filled passively andautomatically. Halkey Roberts self-sealing connections andInterconnectors can also be used in a preattached dialyzerconfiguration, similar to the connections shown in FIG. 8.

As described above in relation to FIGS. 1-3, priming is from the bottomof the blood treatment device 1020 (or dialyzer) on the blood side. Thesaline fills the fibers, pushing any air or other gas or gasses up andout the top end of the blood treatment device into and then down asecond length of tubing 1002 b and into the drain bag 1030. For adialyzer, the saline flows across the membrane into the dialysatechamber. Air or other gas or gasses from the dialysate chamber escapesout the vents on the dialysate ports (for example, Hansen ports) due tothe vents used. The saline continues to flow until the drain bag isfull, stopping the flow of saline. The drain bag is sized to have lessvolume than the combined volume of the saline bags, minus the fluidvolume of the blood treatment device (or dialyzer). The flow of salineis stopped prior to emptying the saline bags so that no air or other gasor gasses is pulled into the freshly primed blood treatment device (ordialyzer).

FIG. 11 is a drawing of a dialyzer system 1100 for use with the primingassembly 1001 with standard luer connections 1040, 1042, pinch clamps1004 and a single saline spike 1003 similar to that of FIG. 10,according to one or more embodiments of the disclosed subject matter.FIG. 11 illustrates the blood treatment device cartridge 1020 embodimentwith connector elements as would come out of the packaging and thatwould facilitate the use of the dialyzer 1020 with the priming assembly1001 of FIG. 10. This is needed because sometimes during the course of adialysis or hemofiltration therapy, the blood treatment device/dialyzer1020 clogs or clots off Instead of discarding the whole disposable, anew dialyzer can be quickly primed and the clogged or clotted dialyzercan be quickly and efficiently changed out. Halkey Roberts self-sealingconnections and Interconnectors can also be used in a configurationsimilar to FIG. 6.

FIG. 12A shows a saline bag 1206 and a drain bag 1204 (which may be anytype of containers) positioned at elevations such that as fluid drainsfrom the saline bag 1206 into the drain bag 1204, the initially highfluid level 1222 of the saline in the saline bag 1206 drops to a samelevel as a level 1226 in the drain bag 1204 as shown in FIG. 12B. Asindicated figuratively by arrows 1209 and 1208, fluid drains through aconnected blood treatment device 1210 according to any of the featuresof the embodiments disclosed above. But rather than relying on the fixedvolume drain bag to halt the flow of priming fluid, the fluid drainsuntil the fluid columns stemming from the drain bag 1204 and saline bag1206 reach equilibrium. A vent 1202 may be provided on the drain bag1204. The vent 1202 may vent gas and prevent ingress of contaminants byisolating a sterile interior of the drain bag 1204 from the externalenvironment using a sterile membrane (not shown). The sterile membranemay be hydrophobic to prevent egress of aqueous fluid from the drain bag1204. A similar vent with a hydrophobic membrane may be used on a fluidline leading to the drain bag 1204 or on the blood treatment device bodyitself.

In embodiments, a saline bag 1206 may be pre-attached to a drain bag1204 as a single article for use in priming. In other embodiments, adual chamber bag may have one chamber full while the other chamberserves as the drain bag. The saline and drain bag dual chamber bags maybe attached to each other as a single unit.

As shown in FIG. 12C, in further embodiments, the saline bag 1230 mayhave an attachment element 1234 such as a hook or hole to fit acomplementary attachment element 1236 of the drain bag 1232 to allow thelatter to be hung from the former. In still further embodiments, thedrain bag 1232 may have an attachment mechanism 1238, such as a loop orstrap to wrap around the blood treatment device 1240, to engage afeature 1242 of the blood treatment device 1240 (such as a ridge arounda header chamber) to allow it to be, in turn, hung from the drain bag1232. As shown in FIG. 12D, the interconnection of the saline and drainbags and the blood treatment device in this embodiment may ensure thecorrect levels of the bags and position and orientation of the bloodtreatment device (with vented caps 1241 in a desirable elevated positionrelative to the remainder of the blood treatment device 1240) to ensurethat the fluid column primes the blood treatment device before reachingequilibrium and to ensure proper venting of air or other gas or gasses.Fluid circuits, with or without self-sealing connectors 1258 and with orwithout tubing clamps, as well as other features with respect to any ofthe various described embodiments are indicated figuratively at 1250 and1252.

FIG. 12E shows a support 1270 with engagement elements 1272, 1273, and1274 shaped and sized to receive a saline container, a drain container,and a blood treatment device (not shown in FIG. 12E). The support 1270may be, for example, a thermoformed panel with cutouts at 1272, 1273,and 1274 shaped and sized to receive a saline container, a draincontainer, and a blood treatment device. Further features such asrecesses or other types of features, indicated at 1276 and 1278 may beshaped to engage features of the saline container, a drain container,and/or blood treatment device shaped. For example, 1278 may be a hook tosupport the saline bag. For another example, 1276 may be a recess andclasp to hold dialyzer port protrusions from the blood treatment deviceso that the vented caps are arranged elevated relative to the bloodtreatment device when the blood treatment device is placed in theengagement element 1274. In an alternative embodiment, the support 1270has an engagement element for a single double chamber bag 1280 as shownin FIG. 12F that includes saline bag 1282 and drain bag 1284 (with vent)as discussed above. The drain bag 1284 may be attached to the saline bagso that the double chamber bag 1280 is supported by the support 1270thereby eliminating a separate engagement element 1273 for the drainbag.

The arrangement of FIG. 12D can be provided with the saline and drainbags preconnected (not the fluid lines, but inter-attached to form aunit as in FIG. 12D) so that the whole assembly can be hung from ahanging element 1231 such as a hole to hang on a hook of a support pole.The arrangement can include the blood treatment device, or not,depending on whether the blood treatment device is supplied as part ofthe packaged article of manufacture. The arrangement of FIG. 12E canalso be provided with the saline and drain bags preconnected (again, notthe fluid lines, but attached to the support 1270 as a unit as in FIG.12E) so that the whole assembly can be hung from a hanging element 1271such as a loop or hole (not shown) to hang on a hook of a support pole.The arrangement can include the blood treatment device, or not,depending on whether the blood treatment device is supplied as part ofthe packaged article of manufacture.

Referring to FIG. 13, a method of priming a treatment device is shown.The operations shown as S2 through S36 may be ordered differently andmay be done in series, parallel, or combinations of series and parallel,according to alternative embodiments and operations may be omittedaccording to still further embodiments. These and the series methodillustrated may also include swapping out a treatment device currentlybeing used for a treatment and replacing it with one primed according tothe method of priming, such as a blood treatment device, may begin withpositioning a priming source at a particular elevation at S10. This mayinclude hanging or positioning a container of priming fluid on a fixture(holder or support being equivalent terms) that ensures the primingfluid source is held at a particular elevation. The purpose is to ensurethat priming fluid can siphon passively through a priming circuit thatis positioned relative to this support and thereby ensure a flow offluid. Alternative mechanisms for causing a flow include providing afluid pump with a mechanism to ensure that the flow can be halted by thegeneration of a predefined head pressure. A pump with a maximum headpressure or a reverse check valve with a recirculation fluid line andcracking pressure may be employed, for example.

At S12, if not already preconnected, a drain container may be connectedto a priming circuit. The priming circuit may be as simple as a tubewith a blood treatment device connector at one end and a drain containerconnector at the other. The tube may have a tubing clamp preattached tothe line. In other embodiments, there may be an intermediate connectorthat is continuous with the tube that allows the connections to beseparated for swapping out a primed blood treatment device as discussedin embodiments herein. The tube intermediate connectors may beself-sealing connectors. As discussed above, the self-sealing connectorsmay be connected by interconnect members that are shaped to connected tothe interconnect members but which interconnect members do not unsealthe self-sealing connectors and thereby cause distortion of an elasticmaterial therein.

A S14, the drain container may be positioned at predefined elevation.This, cooperatively with step S10 ensures that a flow can be establishedpassively through the priming circuit. If an active flow device isemployed, the elevation difference between the priming fluid source andthe drain container may matter less or effectively not at all so stepsS10 and S14 may not be limited to predefined elevations, strictly or atall. Also, the elevations at S10 and S14 may be relative to each other,the absolute positions being irrelevant, as will be understood bypersons of skill in the art, the objective being to flow fluid from asource to a receiver (drain container). Note that equivalent mechanismsfor halting flow are described with reference to FIG. 14 which may beused in alternative methods that do not employ a drain container butotherwise follow the current method operations.

At S16 a treatment device (blood treatment device, dialyzer, or any typeof device as for all the embodiments) is connected to the primingcircuit. The priming circuit may include the portion discussed withrespect to S12 and also a portion to connect the priming fluid source.The latter may take the shape of any of the options discussed relativeto the portion discussed with respect to S12 except that it may connectthe blood treatment device to the priming fluid source. Either portionof the priming circuit may be preconnected to the source and draincontainers and delivered that way or the priming circuit may have sealedconnectors (to maintain sterility of a flow channel therein) forconnection, respectively to the drain and source containers and theblood treatment device to be primed. Again, any time the term bloodtreatment device is used throughout the specification, it may bereplaced by a term for any other device to be primed including any othertype of blood treatment device or other treatment device.

The priming circuits that have interconnect members connecting theirparts may be made continuous flow paths by removing the interconnectmembers and making the respective connection at S18. The main functionof the interconnect members for the intermediate connections is tofacilitate putting the priming circuit components together. If theself-sealing intermediate connectors were connected as delivered, tokeep the independent parts count low in a delivered fluid circuit kit,the self-sealing connectors would suffer distortion of their internalsealing members, which generally being of elastomeric material, suffercreep when strained for an extended period such as during storage andshipment. As in all the embodiments, a function provided by havingintermediate connections is that it provides fluid conveying segmentsfor attachment to a treatment circuit when swapped in and for attachmentto the priming circuit when primed. Effectively it may act as an adapterto permit interconnection between the circuits. In alternativeembodiments, the intermediate connectors, including the self-sealingelements, can be integrated in a blood treatment device in which casethe priming circuit may be simplified. In embodiments with intermediateconnectors that are not self-sealing, the flow paths between theintermediate connectors and either side of the blood treatment devicemay be sealed using manual tube clamps.

At S20, the priming fluid source is connected to the priming fluidcircuit to permit a flow into the blood treatment device. The elevationsof the source and drain having been established to permit a siphon flow,the priming flow will continue S22 without attendance by the operatorand halted by itself S24 without intervention. This allows an operatorto set up a priming operation for a blood treatment device to be swappedin during a treatment without attending to the priming flow. Theoperator may thus establish the priming configuration and then directattention to other matters such as additional patients or an on-goingtreatment operation. In alternative embodiment, particularly ones thatdo not employ natural siphoning but rather use an active pump, the drainmay be any type of drain and the pump may flow a predefined volume, forexample by counting rotations of a peristaltic rotor. Unattended primingmay be provided by such means as well. However, the additional equipmentrequired may be disadvantageous.

One of the functions provided by the unattended priming systems andmethods disclosed herein is to permit the swapping (substitution;replacement) of a treatment device during an on-going treatment withminimal interruption of the treatment and with minimal diversion ofattention by an operator. At S26, which may occur prior to anypreparation for priming at all (i.e., prior to S20), a blood treatmentis established and a need identified for the replacement of one or moreblood treatment devices being used therein, including the bloodtreatment device connected to the priming circuit at S16. In this case,the treatment may involve the use of multiple blood treatment devicesand the method may be done sequentially or contemporaneously to primemultiple blood treatment devices for a single treatment. The need forreplacement of a blood treatment device may manifest as an adverse risein pressure, an indication of a leak in a membrane, an indication ofexpiration of a blood treatment device or a prediction thereof based onvolume of fluid processed, another evident failure or fouling of a bloodtreatment device or any other indication, including a prediction of aneed for replacement or even a risk that blood treatment device may,will, or has ceased functioning in a predefined manner.

Once one or more blood treatment devices has been identified forreplacement, the treatment may be halted or the blood treatment devicebypassed, depending on the type of treatment and system, and the bloodtreatment device to be replaced may be disconnected out of the treatmentsystem at S28. The blood treatment device that has been primed, after atleast a time sufficient to allow full priming at S22, may bedisconnected from the priming circuit at S30. At S32, in embodiments,the disconnection of the blood treatment device from the priming circuitis effective to seal self-sealing connectors connected to the primedblood treatment device. In other embodiments, tube clamps are clampedinstead and the intermediate connectors disconnected. At S34, the primedblood treatment device is connected to the treatment system whichunseals self-sealing connectors if present. Otherwise tubing clamps arereleased. The treatment is then restarted or the bypass of thenow-replaced blood treatment device is eliminated at S36. The bloodtreatment devices swapped in and out by the foregoing method or any ofthe other disclosed methods may be identical such that the type oftreatment performed is not modified by the swapping of the bloodtreatment device. In this and any methods, the blood treatment devicesmay be of any type including hemofilters, dialyzers, apheresis bloodtreatment devices, adsorbent blood treatment devices, and other types oftreatment devices. Blood treatment devices may be of the type known asmicrotubular fiber blood treatment devices commonly used in dialysis.

FIG. 14 shows priming circuit embodiments in which priming fluid flowmay be halted by the generation of a negative pressure in the source offluid rather than by relying on the prevention of flow after the fillingof a fixed volume drain bag. In the present embodiments, priming fluidis supplied through a respective container 1402A-1402C. Container 1402Ahas a float valve a 1404 and a check valve 1406 that allows air or othergas or gasses to be released from the container, for example bysqueezing it, and prevent incursion of air or other gas or gasses backinto the container a 1402A. The float valve 1404 allows fluid to bepushed up to a level that closes the float valve 1404 and the preventionof incursion of air or other gas or gasses back through the check valveprevents the fluid level from falling again. The container 1402A canhave a loop or other engagement mechanism to permit it to be hung in apreferred orientation to ensure the proper operation of the float valve1404. The tube 1403A leads to a connector 1432 as indicated by thedashed line 1416 which shows the three alternative continuous flow pathsfor the three alternative container 1402A-1402C embodiments.

The connector 1432 connects to the remainder of a priming circuitincluding portions that connect to a blood treatment device 1422. Theremainder of the priming circuit may be as in any of the embodiments.For example, the connector pair 1432 and 1430 may be self-sealingconnectors. Or there may be a tube clamp (not shown in the presentdrawing but shown elsewhere) on line 1426 to allow it to be manuallysealed if the connectors 1430 and 1432 are not self-sealing. Line 1424may lead to a drain 1420 which may be a collection container, collectionbag, or a permanent drain fixture or bucket. Since the flow of primingfluid in the present embodiments is halted by starving the suction side,the fixed volume drain container is not required.

In this and other embodiments, a cap 1401 or other type of seal may beprovided to ensure against the leakage of fluid from the container1402A-1402C. The flow path 1416 also indicates here that the containeroutlet 1403A leads to connector 1432. The connector 1432 connects to therest of a priming circuit which includes the other features of thepriming circuit discussed with regard to the other embodiments, namely,first and second intermediate connectors 1432/1430 blood treatmentdevice 1422 with vent caps 1440 and respective lines 1426 and 1424. Itshould be evident from the flow path of the tubes 1424 and 1426 that thepriming circuit may be set up to siphon except that in this case, theflow may be halted by the ebbing of flow from the source side of thecircuit as a result of the starvation of the source and the preventionof a flow of air or other gas or gasses into the priming circuit. Thus,in such embodiments, there is no need for another flow limiter as inother embodiments, such as a drain container, to halt the flow. However,the other flow limiter embodiments may be combined with the sourcestarvation embodiments of the embodiments of FIG. 14 to form furtherembodiments.

Container 1402B has a float valve 1410 in a reverse orientation thatpermits a flow of priming fluid from the container 1402B but blocks aflow of air or other gas or gasses through the float valve 1410. Thefloat valve 1410 also leads to connector 1432. In use, this embodimentallows a priming fluid container that contains air or other gas orgasses to be positioned to generate a siphon and the float valve 1410halts the flow of priming fluid before air or other gas or gasses passesthrough the float valve 1410. Here again, the dashed line 1416 indicatesthat an outlet 1403B is connected to the connector 1432 by a continuouslength of tubing as is the outlet 1403A. A third container 1402C has anair or other gas or gasses purge tube 1412 with a manual tubing pinchclamp 1408 that allows air or other gas or gasses to be purged from thecontainer 1402C, for example by squeezing it. After air or other gas orgasses is fully purged, the manual tubing pinch clamp 1408 can be closedand fluid from the container 1402C may flow by siphon effect to primethe blood treatment device until the container 1402C is starved,whereupon flow halts without any air or other gas or gasses getting intothe priming circuit, at least as far as the blood treatment device 1422.Here again, the dashed line 1416 indicates that an outlet 1403B isconnected to the connector 1432 by a continuous length of tubing as isthe outlet 1403C. Effectively but providing the float valves in the incontainers 1402A and 1402B, the flow of priming fluid is also starved bythe closure of the valve, in the case of 1402A resulting in thestarvation of the flow from the container 1402A itself and in the caseof the container 1402B, by starvation of the flow from the outlet of thecontainer 1402B. Note that a float valve or an equivalent may be placedat a different point in the priming circuit such as along tubes 1426 toprovide a similar effect of preventing air or other gas or gasses fromentering the blood treatment device. Alternatives to the float valvescould be a fully saturated membrane which can prevent the flow of air orother gas or gasses through it by high surface tension forces.

In the embodiments of FIG. 14, the vents connected to the non-blood sidemay include check valves to prevent air from being sucked into the bloodtreatment device.

Referring now to FIGS. 15A, 15B, and 15C, a priming method shown in FIG.15C is for priming in a first direction through a blood treatment deviceand then switching the direction and orientation of the blood treatmentpriming in the opposite direction. Again, the blood circuit of the bloodtreatment device is being primed and all the incidents of the otherembodiments may be applied here as well to form additional embodiments.The new teaching here introduced is the changing of priming direction.This has been found to help to eliminate suborn bubbles in certain typesof blood treatment devices, for example, microtubular fiber bloodtreatment devices such as used in dialysis. The method includesconnecting a priming circuit to a blood treatment device and initialsource and drain containers at S50. S50 also includes positioning theinitial source and drain containers at appropriate elevations to cause aflow from a lower blood port on the blood treatment device to a higherblood port on the blood treatment device so that the priming flow is inan upward direction. Then at S52, the flow is permitted to proceed, suchas by gravity, until it halted, either manually or automatically asdescribed with reference to the embodiments. That is, for example, bystarving the supply or over-filling (pressurizing) the drain container.At S54, after priming in a first direction, the blood treatment deviceis pivoted so that the relative elevations of the blood ports areswitched and the priming fluid source and drain containers are switched.The at S56, the priming flow proceeds again as before in the oppositedirection until at S58 the flow is halted by some means as describedherein or otherwise. FIGS. 15A and 15B show a mechanism for implementingthe method of FIG. 15C. A support 1500 which may take the form of anintravenous pole with upper 1507A and midlevel 1507B hooks. A pivotingsupport 1501 holds a blood treatment device 1525 shown in dashed liensand has two endpoint positions that allow the vented filtrate side portsto expel air or other gas or gasses as the blood treatment device 1525is primed. The pivoting support may permit a user easily to tilt theblood treatment device 1525 for flow in the opposite directionsdescribed with reference to the method of FIG. 15C. The source and draincontainers 1502 and 1503, respectively, can conveniently take swappedpositions by changing the hooks 1507A and 507B on which they are hung.The priming circuit lines 1504 and 1505 may be of any form includingthose described herein, such as ones with a pair of self-sealingconnectors. The lines 1510 and 1511 illustrate the swapping of thepositions of the initial source 1502 and initial drain 1503 containers.Note that the method of claim 15C may include multiple cycles offlow-direction-switching.

FIG. 16A shows a priming circuit 1600A which may take the form of any ofthe disclosed embodiments therefore. FIG. 16B shows a treatment circuitwhich also may take the form of any of the disclosed embodiments. Thepriming circuit 1600A has source 1635A and drain 1635B lines which maybe continuous or interconnected by respective sets of connectors 1612and 1614. As described clamps 1609 may be provided or the connectors1612 and 1614 may be self-sealing. The source line 1635A may have aconnector 1604 such as a male luer which may be connectable to a bagspike 1606 or the connector 1604 may be connectable to a predefinedsource container 1601. The source line 1635A may alternatively bepre-attached, integrally or by connector, to the bag spike 1606. A draincontainer 1602 may be pre-attached or a connector for a collectioncontainer may be connected to the drain line 1635B. Alternatively, thedrain line 1635B may have a termination for use with a drain or bucket1606. When a blood treatment device 1645 is primed, the connectors 1612and 1614 pairs can be disconnected from the rest of the priming circuitand connected to connectors 1617 and 1618 of the treatment circuit 1600Bafter removal of a blood treatment device 1646 currently used in thetreatment circuit 1600B. The connectors 1617 and 1618 may beself-sealing connectors as in any of the other embodiments. Theconnectors 1617 and 1618 may be non-self-sealing connectors as in any ofthe other embodiments. The treatment circuit 1600B may be used with anysuitable treatment machine 1630. The treatment machine 1630 may have adisplay 1612 on which it is programmed to display instructions forperforming any of the methods described in the claims or otherwisedescribed in the instant specification. The priming circuit 1600A andany components thereof may be packaged with printed instructions 1603for performing any of the methods described in the claims or otherwisedescribed in the instant specification.

Any of the methods described herein may be incorporated in, or embodiedin, instructions for use of a priming kit. Instructions for priming ablood treatment device may include instructions for performing one ormore of the following operations.

-   -   Orienting a blood treatment device having first and second blood        ports connected by a blood flow path running through the blood        treatment device such that the first blood port is below the        second blood port, connecting a source of priming fluid to the        first blood port, connecting a drain to the second blood port,        causing the source of priming fluid generates a pressure        sufficient to force priming fluid from the first blood port to        the second blood, stopping the flow of priming fluid before any        air or other gas or gasses enters the first blood port,        disconnecting the blood treatment device without letting any        priming fluid escape, and connecting the blood treatment device        to a blood treatment circuit.    -   Interrupting a blood treatment using the blood treatment circuit        prior to connecting the blood treatment device to the blood        treatment circuit and continuing the blood treatment thereafter.    -   The disconnecting may be effective automatically to seal off the        blood path of the blood treatment device when the blood        treatment device is disconnected.    -   The source of priming fluid may be caused to generate a pressure        sufficient to force priming fluid from the first blood port to        the second by elevating a container of priming fluid above the        second port to cause a flow of priming fluid through the        treatment device by gravity.    -   Before priming the blood treatment device, determine that a        blood treatment device being used for the blood treatment needs        to be replaced by the one to be primed and then proceeding to        prime the one to be primed.    -   Disconnect the primed blood treatment device by undoing        self-sealing connectors and connect the self-sealing connectors        to the blood treatment circuit.    -   Disconnect the primed blood treatment device by clamping adapter        lines connected to the primed blood treatment device and        disconnecting the adapter lines from a remainder of the priming        circuit thereby retaining the priming fluid in the adapter lines        and blood treatment device and connecting the adapter lines to        the blood treatment circuit.    -   The connecting the first blood port to a source of priming fluid        and the connecting the second blood port to a drain includes a        directive to connect a priming circuit with DIN connectors.    -   The connecting the first blood port to a source of priming fluid        and the connecting the second blood port to a drain includes a        directive to connect a priming circuit with a first tube having        a DIN connector and a male luer or bag spike for connection to a        bag of priming fluid and a second tube with a DIN connector and        a connector for attachment to a collection bag.    -   The connecting the first blood port to a source of priming fluid        and the connecting the second blood port to a drain includes a        directive to connect a priming circuit with a first tube having        a DIN connector and a male luer or bag spike for connection to a        bag of priming fluid and a second tube with a DIN connector and        a connector for attachment to a collection bag of inelastic        film, two-layer film such that the collection bag has a        predefined volume, a bag of stretchable film sized to fit a        rigid container such as a bucket or other enclosure to ensure it        can't expand when overfilled.    -   The collection bag may be preattached or the directions may        include a directive to attach the collection bag to the second        tube.    -   The tube may be divided by an interconnector that connects        connectable self-sealing connectors in such a way that their        internal elastomeric seal elements are not strained by the        connection.    -   Disconnect the interconnector and connect the self-sealing        connectors of the first and second tubes prior to priming the        blood treatment device.

Note that in any of the embodiments, the priming fluid container mayalso be a rigid container. The container is sized such that thecombination of the compressed trapped air or other gas or gasses and thefluid in the container stops the flow. Or, the rigid container couldhave an air or other gas or gasses vent that allows the container tofill completely with fluid, functioning similarly to an empty flat bag.

In any of the foregoing method embodiments, a treatment machine thatengages a blood treatment device to be replaced may have a controllerprogrammed to provide instructions to an operator for implementing anyof the disclosed methods. A therapy machine with a monitor, userinterface and software that facilitates the swapping of blood treatmentdevices or the addition of blood treatment devices, and a disposablebloodline/fluid line assembly with extra connections that facilitatesthe connection of a replacement blood treatment device and/or theaddition of specialty blood treatment devices as prescribed by thephysician. Monitor and software give prompts and feedback to the userabout how and when to prime and connect blood treatment devices to thebloodline/fluid line assembly. The therapy machine specifically allowsand facilitates swapping and/or addition of blood treatment devices, aswell the bloodline/fluid line assembly has appropriate connectors tofacilitate swapping and/or addition of blood treatment devices.

In one or more first embodiments, a tubing set can comprise a bag spike,a first tube, and a second tube. The bag spike is adapted for connectingto a predefined type of medical fluid bag. The medical fluid bag can beof a type having a predefined volume of fluid. The first tube isconnected to the bag spike at an inlet end. An outlet end of the firsttube has a first blood treatment device connector adapted for connectionto a predefined blood treatment device at a first blood port thereof.The second tube has a second blood treatment device connector adaptedfor connection to the predefined blood treatment device at a secondblood port thereof. The second tube can be connected to a bag (e.g., adrain bag) whose elastic properties and size are selected to ensure thatthe predefined volume of fluid held by the predefined type of medicalfluid bag connectable by the bag spike is substantially more than bloodand non-blood compartments volume of the predefined blood treatmentdevice plus the volume of the drain bag.

In the first embodiments or any other embodiment, the drain bag is ofnylon or other sufficiently strong sheet materials.

In the first embodiments or any other embodiment, the drain bag is ofinelastic film.

In the first embodiments or any other embodiment, the predefined bloodtreatment device has self-sealing connectors that close and stop flowwhen disconnected.

In one or more second embodiments, a blood treatment device priming setcan comprise a drain bag, a bag spike, and first and second tubes. Thebag spike can be constructed to connect to a medical fluid bag having apredefined volume of fluid. The first tube has inlet and outlet ends.The first tube can be constructed to connect to the bag spike at theinlet end. The outlet end has a first blood treatment device connectorconstructed to connect to a first blood port of a blood treatmentdevice. The second tube can be connected to the drain bag. The secondtube has a second blood treatment device connector constructed toconnect to a second blood port of the blood treatment device. The drainbag has elastic properties and a volume selected to ensure that thepredefined volume of fluid held by the medical fluid bag is more than avolume of blood and non-blood compartments of the blood treatment deviceplus a volume of the drain bag.

In the second embodiments or any other embodiment, the drain bagincludes at least one layer of nylon or is of nylon.

In the second embodiments or any other embodiment, the drain bag is ofinelastic film.

In the second embodiments or any other embodiment, the predefined bloodtreatment device has self-sealing connectors that close and stop flowwhen disconnected.

In one or more third embodiments, a method of priming comprisesconnecting the set of any of the first and second embodiments, or anyother embodiment, to the blood treatment device and permitting fluid toflow by gravity therethrough from the medical fluid bag to the drainbag. The method can further include permitting fluid to flow until thefluid is stopped by the attainment of a maximum capacity of the drainbag.

In the third embodiments or any other embodiment, the method can furthercomprise, when a currently-in-use blood treatment device being used in ablood treatment needs to be replaced, disconnecting said set from saidblood treatment device and replacing said currently-in-use bloodtreatment device with said blood treatment device immediatelythereafter.

In one or more fourth embodiments, a tubing set can comprise multiplebag spikes, and multiple tubes. Each bag spike is adapted for connectingto a predefined type of medical fluid bag. The medical fluid bag can beof a type having a predefined volume of fluid. Each one of the multipletubes is connected to a separate one of the multiple bag spikes at aninlet end. An outlet end of each of the multiple tubes is connected to amulti-way connector to combine the contents of each of the multipletubes into a single first tube that has a first blood treatment deviceconnector adapted for connection to a predefined blood treatment deviceat a first blood port thereof. The first tube has a first connector witha first portion and a second portion positioned between the multi-wayconnector and the first blood treatment device connector with a firstinterconnector positioned between and connected to the first portion andthe second portion. A second tube has a second blood treatment deviceconnector at one end adapted for connection to the predefined bloodtreatment device at a second blood port thereof. The second tube at anopposite end is adapted for connection to a bag (e.g., a drain bag)whose elastic properties and size are selected to ensure that thepredefined volume of fluid held by the predefined type of medical fluidbag connectable by the bag spike is substantially more than blood andnon-blood compartments volume of the predefined blood treatment deviceplus the volume of the drain bag. The second tube has a second connectorwith a first portion and a second portion positioned between the secondblood treatment device connector and the second tube opposite end with asecond interconnector positioned between and connected to the firstportion and the second portion. A pressure measurement pod is connectedto the second tube adjacent to the second blood treatment deviceconnector.

In the fourth embodiments or any other embodiment, the drain bag is ofnylon.

In the fourth embodiments or any other embodiment, the drain bag is ofinelastic film.

In the fourth embodiments or any other embodiment, the predefined bloodtreatment device has self-sealing connectors that close and stop flowwhen disconnected.

In the fourth embodiments or any other embodiment, the first and secondinterconnectors do not permit flow.

In one or more fifth embodiments, a blood treatment device priming setcan comprise a drain bag, multiple bag spikes, and multiple tubes. Eachbag spike is adapted for connecting to a predefined type of medicalfluid bag. The medical fluid bag can be of a type having a predefinedvolume of fluid. Each one of the multiple tubes is connected to aseparate one of the multiple bag spikes at an inlet end. An outlet endof each of the multiple tubes is connected to a multi-way connector tocombine the contents of each of the multiple tubes into a single firsttube that has a first blood treatment device connector adapted forconnection to a predefined blood treatment device at a first blood portthereof. The first tube has a first connector with a first portion and asecond portion positioned between the multi-way connector and the firstblood treatment device connector. A second tube has a second bloodtreatment device connector at one end adapted for connection to thepredefined blood treatment device at a second blood port thereof. Thesecond tube at an opposite end can be connected to a bag (e.g., a drainbag) whose elastic properties and size are selected to ensure that thepredefined volume of fluid held by the predefined type of medical fluidbag connectable by the bag spike is substantially more than blood andnon-blood compartments volume of the predefined blood treatment deviceplus the volume of the drain bag. The second tube has a second connectorwith a first portion and a second portion positioned between the secondblood treatment device connector and the second tube opposite end. Apressure measurement pod is connected to the second tube adjacent to thesecond blood treatment device connector.

In the fifth embodiments or any other embodiment, the drain bag is ofnylon.

In the fifth embodiments or any other embodiment, the drain bag is ofinelastic film.

In the fifth embodiments or any other embodiment, the predefined bloodtreatment device has self-sealing connectors that close and stop flowwhen disconnected.

In one or more sixth embodiments, a tubing set can comprise multiple bagspikes, and multiple tubes. Each bag spike is adapted for connecting toa predefined type of medical fluid bag. The medical fluid bag can be ofa type having a predefined volume of fluid. Each one of the multipletubes is connected to a separate one of the multiple bag spikes at aninlet end. An outlet end of each of the multiple tubes is connected to amulti-way connector to combine the contents of each of the multipletubes into a single first tube that has a first blood treatment deviceconnector adapted for connection to a predefined blood treatment deviceat a first blood port thereof. The first tube has a first connector witha first portion and a second portion positioned between the multi-wayconnector and the first blood treatment device connector with a firstinterconnector positioned between and connected to the first portion andthe second portion. A second tube has a second blood treatment deviceconnector at one end adapted for connection to the predefined bloodtreatment device at a second blood port thereof. The second tube at anopposite end is adapted for connection to a bag (e.g., a drain bag)whose elastic properties and size are selected to ensure that thepredefined volume of fluid held by the predefined type of medical fluidbag connectable by the bag spike is substantially more than blood andnon-blood compartments volume of the predefined blood treatment deviceplus the volume of the drain bag. The second tube has a second connectorwith a first portion and a second portion positioned between the secondblood treatment device connector and the second tube opposite end with asecond interconnector positioned between and connected to the firstportion and the second portion. A pair of vented Hansen caps forconnecting to the blood treatment device can also be included.

In the sixth embodiments or any other embodiment, the drain bag is ofnylon.

In the sixth embodiments or any other embodiment, the drain bag is ofinelastic film.

In the sixth embodiments or any other embodiment, the predefined bloodtreatment device has self-sealing connectors that close and stop flowwhen disconnected.

In the sixth embodiments or any other embodiment, the first and secondinterconnectors do not permit flow.

In one or more seventh embodiments, a blood treatment device priming setcan comprise a drain bag, multiple bag spikes, and multiple tubes. Eachbag spike is adapted for connecting to a predefined type of medicalfluid bag. The medical fluid bag can be of a type having a predefinedvolume of fluid. Each one of the multiple tubes is connected to aseparate one of the multiple bag spikes at an inlet end. An outlet endof each of the multiple tubes is connected to a multi-way connector tocombine the contents of each of the multiple tubes into a single firsttube that has a first blood treatment device connector adapted forconnection to a predefined blood treatment device at a first blood portthereof. The first tube has a first connector with a first portion and asecond portion positioned between the multi-way connector and the firstblood treatment device connector with a first interconnector positionedbetween and connected to the first portion and the second portion. Asecond tube has a second blood treatment device connector at one endadapted for connection to the predefined blood treatment device at asecond blood port thereof. The second tube at an opposite end can beconnected to a bag (e.g., a drain bag) whose elastic properties and sizeare selected to ensure that the predefined volume of fluid held by thepredefined type of medical fluid bag connectable by the bag spike issubstantially more than blood and non-blood compartments volume of thepredefined blood treatment device plus the volume of the drain bag. Thesecond tube has a second connector with a first portion and a secondportion positioned between the second blood treatment device connectorand the second tube opposite end with a second interconnector positionedbetween and connected to the first portion and the second portion. Apair of vented Hansen caps for connecting to the blood treatment devicecan also be included.

In the seventh embodiments or any other embodiment, the drain bag is ofnylon.

In the seventh embodiments or any other embodiment, the drain bag is ofinelastic film.

In the seventh embodiments or any other embodiment, the predefined bloodtreatment device has self-sealing connectors that close and stop flowwhen disconnected.

In one or more eighth embodiments, a tubing set can comprise a bagspike, a first tube, and a second tube. The bag spike is adapted forconnecting to a predefined type of medical fluid bag. The medical fluidbag can be of a type having a predefined volume of fluid. The first tubeis connected to the bag spike at an inlet end. An outlet end of thefirst tube has a first blood treatment device connector adapted forconnection to a predefined blood treatment device at a first dialysateport thereof. The second tube has a second blood treatment deviceconnector adapted for connection to the predefined blood treatmentdevice at a second dialysate port thereof. The second tube at anopposite end is adapted for connection to a bag (e.g., a drain bag)whose elastic properties and size are selected to ensure that thepredefined volume of fluid held by the predefined type of medical fluidbag connectable by the bag spike is substantially more than blood andnon-blood compartments volume of the predefined blood treatment deviceplus the volume of the drain bag.

In the eighth embodiments or any other embodiment, the drain bag is ofnylon.

In the eighth embodiments or any other embodiment, the drain bag is ofinelastic film.

In the eighth embodiments or any other embodiment, the predefined bloodtreatment device has self-sealing connectors that close and stop flowwhen disconnected.

In one or more ninth embodiments, a blood treatment device priming setcan comprise a drain bag, a bag spike, a first tube, and a second tube.The bag spike is adapted for connecting to a predefined type of medicalfluid bag. The medical fluid bag can be of a type having a predefinedvolume of fluid. The first tube is connected to the bag spike at aninlet end. An outlet end of the first tube has a first blood treatmentdevice connector adapted for connection to a predefined blood treatmentdevice at a first dialysate port thereof. The second tube has a secondblood treatment device connector adapted for connection to thepredefined blood treatment device at a second dialysate port thereof.The second tube can be connected to a bag (e.g., a drain bag) whoseelastic properties and size are selected to ensure that the predefinedvolume of fluid held by the predefined type of medical fluid bagconnectable by the bag spike is substantially more than blood andnon-blood compartments volume of the predefined blood treatment deviceplus the volume of the drain bag.

In the ninth embodiments or any other embodiment, the drain bag is ofnylon.

In the ninth embodiments or any other embodiment, the drain bag is ofinelastic film.

In the ninth embodiments or any other embodiment, the predefined bloodtreatment device has self-sealing connectors that close and stop flowwhen disconnected.

In one or more tenth embodiments, a method of treatment includesconnecting a plurality of bag spikes to separate medical fluid bags witheach bag having a predefined volume of fluid and a first tube beingconnected to the plurality of bag spikes at an inlet end and connectingan outlet end of the first tube having a first blood treatment deviceconnector adapted for connection to a predefined blood treatment deviceat a first blood port thereof. The method can also include connecting asecond tube having a second blood treatment device connector adapted forconnection to the predefined blood treatment device and a pressuremeasurement pod adjacent and distal to the second blood treatment deviceconnector at a second blood port thereof with an outlet end of thesecond tube being connected to a drain bag; filling the blood treatmentdevice with fluid from the medical fluid bags to prime the bloodtreatment device; and disconnecting the primed blood treatment devicefrom the first tube and the second tube. The method can still furtherinclude disconnecting a used blood treatment device from a dialysissystem; and connecting the primed blood treatment device to the dialysissystem.

In one or more eleventh embodiments, a method of treatment includesconnecting a plurality of bag spikes to separate medical fluid bags atan inlet end and connecting an outlet end of the first tube having afirst blood treatment device connector adapted for connection to apredefined blood treatment device at a first blood port thereof. Themethod can also include connecting a second tube having a second bloodtreatment device connector adapted for connection to the predefinedblood treatment device at a second blood port thereof with an outlet endof the second tube being connected to a drain bag; filling the bloodtreatment device with fluid from the medical fluid bags to prime theblood treatment device; and disconnecting the primed blood treatmentdevice from the first tube and the second tube. The method can stillfurther include disconnecting a used blood treatment device from adialysis system; and connecting the primed blood treatment device to thedialysis system.

In one or more twelfth embodiment, a method for performing a bloodtreatment, includes flowing blood from a patient through anextracorporeal blood treatment system that uses a replaceable bloodtreatment device. The method includes detecting a condition indicating aneed to replace the replaceable blood treatment device. The methodincludes priming a blood treatment device to provide a primed bloodtreatment device and replacing the replaceable blood treatment devicewith the primed blood treatment device.

According to variations thereof, in the one or more twelfth embodiments,the detecting includes detecting a change in a pressure of a bloodcircuit. According to variations thereof, in the one or more twelfthembodiments, the detecting includes detecting a pressure propertyindicating a rise in pressure drop through the replaceable bloodtreatment device. According to variations thereof, in the one or moretwelfth embodiments, the flowing includes performing an extracorporealblood treatment. According to variations thereof, in the one or moretwelfth embodiments, the flowing includes performing a hemodialysis,hemofiltration, apheresis, or a type of renal replacement therapytreatment. According to variations thereof, in the one or more twelfthembodiments, the priming includes creating a siphon flow in a primingcircuit and automatically halting the siphoning flow prior to an entryof air or other gas or gasses into the fluid circuit. According tovariations thereof, in the one or more twelfth embodiments, theautomatically halting includes the passive starvation of a flow from apriming source. According to variations thereof, in the one or moretwelfth embodiments, the automatically halting includes the completefilling of a fluid-receiving device until it can hold no further fluid.According to variations thereof, in the one or more twelfth embodiments,the receiving device includes a drain bag of inelastic material.According to variations thereof, in the one or more twelfth embodiments,the receiving device includes a drain bag of relatively inelastic andrelatively elastic materials bonded as a dual layer film. According tovariations thereof, in the one or more twelfth embodiments, thereceiving device includes a drain container with a maximum fill volumethat is less than a total volume of fluid of a source container less avolume of the primed blood treatment device less a volume of a primingcircuit between the primed blood treatment device and the draincontainer. According to variations thereof, in the one or more twelfthembodiments, the replacing includes disconnecting the primed bloodtreatment device from a priming circuit using self-sealing connectors.According to variations thereof, in the one or more twelfth embodiments,the self-sealing connectors remain connected to the primed bloodtreatment device after said disconnecting by means of lengths of tubing.According to variations thereof, in the one or more twelfth embodiments,the replacing includes clamping fluid lines attached to the primed bloodtreatment device prior to disconnecting the primed blood treatmentdevice from a priming circuit and keeping the clamped fluid linesattached to the blood treatment device. According to variations thereof,in the one or more twelfth embodiments, the replacing includesconnecting the clamped fluid lines to a blood circuit. According tovariations thereof, in the one or more twelfth embodiments, the draincontainer is a bilayer bag that includes a layer of nylon. According tovariations thereof, in the one or more twelfth embodiments, the draincontainer is a bilayer bag that includes two layers of film, a first alayer of the two layers of film being stiffer than a second of the twolayers of film. According to variations thereof, in the one or moretwelfth embodiments, the priming includes creating a siphon flow in apriming circuit and automatically halting the siphoning flow prior to anentry of air or other gas or gasses into the fluid circuit, wherein theautomatically halting includes the passive starvation of a flow from apriming source by means of a valve that blocks the passage of air orother gas or gasses from a priming source but permits flow of primingfluid. According to variations thereof, in the one or more twelfthembodiments, the valve includes a float valve. According to variationsthereof, in the one or more twelfth embodiments, the valve includes awetted membrane. According to variations thereof, in the one or moretwelfth embodiments, the automatically halting includes the completefilling of a fluid-receiving device until it can hold no more to preventair or other gas or gasses from entering the primed blood treatmentdevice. According to variations thereof, in the one or more twelfthembodiments, the automatically halting includes the complete filling ofa fluid-receiving device until it can hold no more while maintaining acolumn of fluid to a level above the primed blood treatment device.According to variations thereof, in the one or more twelfth embodiments,priming includes providing a priming circuit with two lines connectableto blood ports of the primed blood treatment device, each line includingtwo interconnected line portions. According to variations thereof, inthe one or more twelfth embodiments, the to line portions areinterconnected by self-sealing connectors, portions of which areconnectable to a blood circuit to permit said replacing. According tovariations thereof, in the one or more twelfth embodiments, the primingincludes disconnecting an interconnector member from each of saidself-sealing connector portions and connecting said self-sealingconnector portions to interconnect said two line interconnected portionsto form continuous flow paths in said two lines. According to variationsthereof, in the one or more twelfth embodiments, the interconnectormember connects respective ones of said connector portions in such a waythat seals thereof are in an unstrained state. According to variationsthereof, in the one or more twelfth embodiments, the seals thereof areelastomeric material subject to creep upon being strained.

In any of the method, device, or system embodiments that include oremploy an interconnect member the interconnect member may be shaped toprovide a sterile barrier between lumens of two predefined connectorsforming an interconnectable pair. The sterile barrier may include atortuous path between the lumens and an external environment.

Any of the embodiments that are described as including or employing ablood treatment device, including the embodiments defined by the claims,it will be understood that such embodiments may be modified to form anadditional embodiment in which the blood treatment device is replacedwith any type of blood treatment device or any type of conditioningelement that requires priming.

In any of the embodiments, including those defined by the claims, aconnector that connects to a blood treatment device may limited to onethat conforms to American National Standards Institute(ANSI)/Association for the Advancement of Medical Instrumentation(AAMI)/International Organization for Standardization (ISO) for theconnection of blood ports of a cardiovascular implant, extracorporealsystem, hemodialyzer, hemodiablood treatment device, hemofilter orhemoconcentrator. In any of the embodiments, such a connector may belimited to one that conforms to ANSI/AAMI/ISO 8637:2010.

Although blood treatment devices that process blood are specificallydisclosed herein, it is further contemplated that the systems, methods,and devices described herein can be applied to any types of fluid bloodtreatment devices including, for example, blood treatment devices thatprocesses a bodily fluid other than blood. Accordingly, embodiments ofthe disclosed subject matter are not limited to a particular class ofblood treatment devices.

Furthermore, the foregoing descriptions apply, in some cases, toexamples generated in a laboratory, but these examples can be extendedto production techniques. For example, where quantities and techniquesapply to the laboratory examples, they should not be understood aslimiting. In addition, although specific chemicals and materials havebeen disclosed herein, other chemicals and materials may also beemployed according to one or more contemplated embodiments.

In this application, unless specifically stated otherwise, the use ofthe singular includes the plural and the use of “or” means “and/or.”Furthermore, use of the terms “including” or “having,” as well as otherforms, such as “includes,” “included,” “has,” or “had” is not limiting.Any range described herein will be understood to include the endpointsand all values between the endpoints.

In any of the embodiments, the blood treatment devices employed may beof any type including adsorbent based blood treatment devices such ashemoperfusion blood treatment devices, liver replacement blood treatmentdevices, microtubular fiber blood treatment devices, electrodialysisblood treatment devices, hemofilters, dialyzers, oxygenators, or anyother type of blood treatment device or any other therapy device thatallows the blood to flow through, especially those used inextracorporeal blood treatments.

In any of the method embodiments including a blood treatment, the methodmay include the performance of the blood treatment without anticoagulantor the use of anticoagulant at a reduced level. In the modified method,rather than rely on anticoagulant such as citrate or heparin to preventto minimize clotting, the blood treatment device circuit, where the riskof clotting is greatest, typically occurs, is monitored for someindication of clogging. This may be may be predicted, progressive,actual, or inchoate clogging. Indicators of clogging may be a trend inpressure loss through the blood side of the blood treatment device,observation of the color of the blood treatment device, or some otherindication. The user then determines to swap out the clogging bloodtreatment device or is prompted to by the therapy machine software anduser interface. By simply swapping out the clogged blood treatmentdevice with a fresh blood treatment device and preserving the bloodlineand fluid set assembly, time and costs are saved.

Any of the self-sealing valves may be of the Halkey-Roberts type invarious arrangements such as, for example, described in European PatentPublication EP1632264 to Halkey-Roberts Corporation. The details are notexplained in the instant application because these types of connectorsare known in the art and well-understood by those of skill in the art.But for purposes of convenience, in an example embodiment, a valveactivation element shaped as a male luer pushes on an elastomeric valvesealing element changing its shape so as to open a passage in the maleconnector. In the embodiment, a female luer is covered by an elastomericcover that is opened in piercing fashion by the male luer-shaped valveactivation element of the other connector. Both elastomeric elementsrestore to a rest position that seals the openings of the respectiveconnector. If either is maintained in an open state, come degree ofyield or creep may occur preventing the rest position from sealingcompletely. A kit of the priming assembly is packaged and sterilized forthe convenience of the user. The kit also contains instructions forperforming the prime.

Note that in any of the embodiments or in the claims, the connectors forthe blood treatment devices may be limited to the ISO standard mentionedhere or to some other standard. Also, in any embodiment, a priming flowpath through the blood treatment device may be open for the expulsion ofgas or air or other gas or gasses. Also, at any point in the instantapplication or claims where air or other gas or gasses is identified, itwill be appreciated that the disclosed subject matter is not limited tocircumstances involving air or other gas or gasses and other gases maybe involved such that the disclosure and claims may be read asindicating any type of gas.

Note that in any of the embodiments, the blood compartment of a bloodtreatment device may form a continuous circuit with the priming circuitbetween a source of priming fluid and a drain. The flow is halted by thedrain. However, in any and all embodiments, the blood treatment devicemay have a porous media separating the blood compartment from anon-blood compartment such that in embodiments where vents are attachedto the non-blood compartment, since the blood path is effectively opento the non-blood path due to the porous media, the continuous path isopen to the outside. However, by selection of a hydrophobic vent, thecircuit between the source of priming fluid and the drain can be closed.In embodiments where the choking of flow from the source side is used tohalt the flow, the vents can include check valves to prevent air frombeing sucked into the blood treatment device during priming.++

Features of the disclosed embodiments may be combined, rearranged,omitted, etc., within the scope of the invention to produce additionalembodiments. Furthermore, certain features may sometimes be used toadvantage without a corresponding use of other features.

It is thus apparent that there is provided in accordance with thepresent disclosure, system, methods, and devices for priming a bloodtreatment device. Many alternatives, modifications, and variations areenabled by the present disclosure. While specific embodiments have beenshown and described in detail to illustrate the application of theprinciples of the present invention, it will be understood that theinvention may be embodied otherwise without departing from suchprinciples. Accordingly, Applicant intends to embrace all suchalternatives, modifications, equivalents, and variations that are withinthe spirit and scope of the present invention.

1. A method for performing a blood treatment, comprising: flowing bloodfrom a patient through an extracorporeal blood treatment system thatuses a replaceable blood treatment device; detecting a conditionindicating a need to replace the replaceable blood treatment device;priming a blood treatment device to provide a primed blood treatmentdevice; and replacing the replaceable blood treatment device with theprimed blood treatment device.
 2. The method of claim 1, wherein thedetecting includes detecting a change in a pressure of a blood circuit.3. The method of claim 2, wherein the detecting includes detecting apressure property indicating a rise in pressure drop through thereplaceable blood treatment device.
 4. The method of claim 1, whereinthe flowing includes performing a hemodialysis, hemofiltration,apheresis, or a type of renal replacement therapy treatment.
 5. Themethod of claim 1, wherein the priming includes creating a siphon flowin a priming circuit and automatically halting the siphoning flow priorto an entry of air or other gas or gasses into a fluid circuit of theextracorporeal blood treatment system.
 6. The method of claim 5, whereinthe automatically halting includes a passive starvation of a flow from apriming source.
 7. The method of claim 5, wherein the automaticallyhalting includes a complete filling of a fluid-receiving device until itcan hold no further fluid.
 8. The method of claim 7, wherein thereceiving device includes a drain bag of inelastic material.
 9. Themethod of claim 7, wherein the receiving device includes a drain bag ofrelatively inelastic and relatively elastic materials bonded as a duallayer film.
 10. The method of claim 7, wherein the receiving deviceincludes a drain container with a maximum fill volume that is less thana total volume of fluid of a source container less a volume of theprimed blood treatment device less a volume of a priming circuit betweenthe primed blood treatment device and the drain container.
 11. Themethod of claim 1, wherein the replacing includes disconnecting theprimed blood treatment device from a priming circuit using self-sealingconnectors.
 12. The method of claim 10, wherein the drain container is abilayer bag that includes two layers of film, a first a layer of the twolayers of film being stiffer than a second of the two layers of film.13. The method of claim 1, wherein the priming includes creating asiphon flow in a priming circuit and automatically halting the siphoningflow prior to an entry of air or other gas or gasses into a fluidcircuit of the extracorporeal blood treatment system, wherein theautomatically halting includes a passive starvation of a flow from apriming source by a valve that blocks passage of air or other gas orgasses from a priming source but permits flow of priming fluid.